A Randomized, Phase II ECOG Trial of Two Dose Levels of CCI-779 in Patients With Extensive-Stage Small Cell Lung Cancer Who Have Responding or Stable Disease After Induction Chemotherapy

Inclusion Criteria:

- Patients must have histologically-confirmed small cell carcinoma of the lung or
unequivocally positive cytological evidence (sputum [at least 2] or aspirate biopsy),
with extensive disease (disease beyond the hemithorax and adjacent nodes,
supraclavicular node involvement or pleural effusion with positive cytology), who
have required induction chemotherapy, who have responding or stable disease, and who
meet the following criteria:

- Induction chemotherapy including platinum (cisplatin or carboplatin) plus either
etoposide (VP-16) or irinotecan (CPT-11)

- A minimum of 3 and a maximum of 6 cycles of induction chemotherapy have been
administered

- Recovered from all toxicity related to prior chemotherapy (except alopecia
and/or neuropathy)

- No less than 4 and no more than 8 weeks have elapsed between the last treatment
of induction chemotherapy and randomization

- No more than 32 weeks have elapsed between the first dose of induction
chemotherapy and date of randomization

- The patient has responding or stable disease using RECIST criteria since the
initiation of systemic chemotherapy (i.e., patients who have exhibited disease
progression are NOT ELIGIBLE)

- Patients must be disease-free for >= 5 years if they have had a prior second
malignancy other than treated basal cell or squamous cell skin cancer, or carcinoma
in situ of the cervix

- Baseline measurements/evaluations of disease must be obtained =< 4 weeks prior to
randomization

- WBC >= 4000/mm³ or

- ANC >= 1500/mm³

- Platelet count >= 100,000/mm³

- Total bilirubin =< 1.5 mg/dl

- Creatinine =< 1.5 mg/dl

- Patient's cholesterol level must be < 350mg/dl; (note; if non-fasting levels are high
repeat in a fasting state)

- Patient's triglycerides must be < 400mg/dl; (note; if non-fasting levels are high
repeat in a fasting state)

- ECOG performance status 0, 1, or 2

- Prior radiation to any symptomatic site is permitted so long as the site(s) of
measurable disease are NOT irradiated, and radiation is completed at least 4 weeks
before randomization

- Patients must not have had prior treatment with biological response modifiers

- Patients with brain metastases are eligible provided they have received treatment,
are asymptomatic and are no longer taking corticosteroids; patients who develop brain
metastases after completion of induction chemotherapy are ineligible

- Patients must not be on anticonvulsant therapy

- Patients must not have limited disease

- Patients must not become pregnant and must practice adequate contraception; women of
child-bearing potential and men must agree to use adequate contraception (hormonal or
barrier method of birth control) prior to study entry, for the duration of study
participation and continue approximately 12 weeks after the study is completed;
should a woman become pregnant or suspect she is pregnant while participating in this
study, she should inform her treating physician immediately; female patients who are
breastfeeding are also excluded from this study

- Patients must not have history of allergic reactions attributed to compounds of
similar chemical or biologic composition to CCI-779, or to any of the components of
the CCI-779 formulation; patients must also not be allergic to or for medical reasons
are unable to receive antihistamines

- Patients must not be immunocompromised, have an active infection or serious
intercurrent infection, or have received known immunosuppressive therapies within 3
weeks randomization